A randomized controlled trial of primary tamoxifen versus mastectomy plus adjuvant tamoxifen in fit elderly women with breast carcinoma of high estrogen receptor content: Long-term results at 20 years of follow-up.

536 Background: Long-term analysis of a randomized controlled trial (RCT) in Nottingham comparing surgery with tamoxifen as initial treatment demonstrated that, in unselected cases, surgery achieves better local control. However, it was also suggested that for patients with oestrogen receptor (ER) rich tumours, local control rates may be comparable. We now present long-term follow-up of a further RCT designed to clarify this group. Methods: Between 1989-1996, 153 fit elderly (≥70 years) women of mean age 78 years (range 70-93) with clinically node negative primary breast carcinoma <5cm of high ER content (H-score ≥ 100) were randomised to primary tamoxifen (n=100) or mastectomy with adjuvant tamoxifen (n=53). Randomization was 2:1 in favor of tamoxifen in order to detect the events in this group. Results: With a median follow-up of 78 months (range 6-237) there was no significant difference in breast cancer specific survival, metastatic status or regional recurrence between the treatment arms; however, lo...